Melissa L. Ray, MBA, BSE...

Phoenix, AZ • 602-***-**** • aculzc@r.postjobfree.com • www.linkedin.com/in/raymelissa • www.melray.co

Visionary and Entrepreneurial C-level Executive with 15 Years of Industry Experience – Chief Operating Officer who propels business strategy through administrative management, technological development, strategic planning, compliance, and process engineering on an international level. An ambitious, engaging and inspirational leader, adept at optimizing market potential through product innovation, operational excellence, and highly efficient go-to-market strategies across a variety of industries including healthcare, biotechnology and manufacturing for medical devices. Leverages keen financial acumen and cross-vertical expertise along with infrastructure building and strong focus on customer service to develop robust organizations. Recognized as a committed leader, collaborator, and negotiator with the Board who builds consensus with key stakeholders and a respected, business savvy, trusted advisor and encouraging mentor. Notable contributions:

Spearheaded concept and drove all build out operations for a spinoff company, overseeing Legal, Finance, HR, IT, Project Management, and Compliance Departments with a $50M budget.

Developed a portfolio of Administrative, IT, Compliance and Quality Assurance Documents to manage all operations of a start-up company.

Directed entire international biorepository development, from coordination and construction, LIMS software product development, through successful project implementation. Drove quality assurance and validation standards development for the successful, commercialization for new innovative LIMS software, on time/on budget while meeting corporate goals.

Dedicated to team development: Coached, mentored, motivated and cultivated staff, helping to position them into future Leadership roles. Showing Interpersonal Communication Skills.

Driving Corporate Value through Business Performance Leadership

Client Relations and Customer Service

Product Management Product Lifecycle

Legal Contract Negotiation Business Process

Mission Driven Mission Execution

Regulatory Compliance Crisis Intervention

Products Innovation and Products Development

Corporate Integrity

Fiscal Management Financial Results

Strategic Alliances Develop New Programs

International Business Business Knowledge

Recruiting, Mentoring, Motivating and Coaching

Operations Management Business Plans

Cost Benefit Analysis Operations

Product Marketing and Branding Image

Identifies Economic Opportunities

Patient Advocate

Build Relationships Build Partnerships

License Intellectual Property

Leadership Accountable Vision

ISO, Quality Assurance and Quality Improvement

Process Improvement Six Sigma KPI’s

Project Management Program Implementation

Risk Management Change Management

Service Delivery Strategic Thinking

Driven, Visionary Business Builder with Multidiscipline Expertise

TRANSLATIONAL GENOMICS RESEARCH INSTITUTE (TGen) – Phoenix, AZ 2006 – 2015

Ashion Advanced Individual Medicine (AIM), – Phoenix, AZ 2014 – 2015

TGen inspired spin off company; national company integrating genomic knowledge into medical practice through expertise, education and research. $12M in revenue and 41 employees and consultants.

VICE PRESIDENT, ADMINISTRATION

Promoted by TGen as employee #1 to create concept, build and oversee the corporate administrative functions for this start-up portfolio of companies. Oversaw Legal, Finance, HR, IT, Project Management and Compliance departments and outsourced services with a $50M budget. Along with the Board, hired and closely collaborated with CEO and in business strategy development for Ashion. Managed a varity of Contractors six direct and 25 indirect reports.

Implementation Success: Ensured effective implementation and maintenance, including planning, content, organizing, motivating, and controlling resources to achieve specific goals such as oversight for the Education, Reimbursement, and Clinical Research Programs, among others.

Developed the Business Manual per Board deadlines, including Company History, Letter from the CEO, Board Operating Policy, Operations Manual and PMC Operations Manual addressing medical affairs.

Oversaw the development of a reimbursement process based on new CMS requirements for large whole genome panels and responses to denied claims to get positive responses.

Operations Excellence: Led Ashion’s operations infrastructure development from the ground up.

Steered the VP of Finance and Controller in the selection and acquisition of appropriate Limited Liability Insurance, subleased the space that would be occupied while researching new space.

Oversaw web development, coordinating both companies’ messaging, Search Engine Optimization, marketing and branding, ensuring alignment and establishing Ashion’s entity, and presenting it to the board for approval. Utilized as the primary source for company internet marketing and advertising.

Successful Build Out: Drove Ashion’s complete strategy and build out of operations, both through the outsourced TGen partnership and Ashion’s internal infrastructure development.

Oversaw and managed the successful completion of the initial Healthcare System 100-day plan, resulting in five built out PMCs, two draft web pages and the effective negotiation of numerous documents.

Established Ashion’s hardware/software agreements, cloud capabilities (Network infrastructure) and project management structure.

Successfully negotiated Ashion’s first Healthcare System agreement, garnering the first income of $25M.

Saved 20%, or $600K through contract negotiations.

Directed internal Ashion Information Technology in creating and implementing Regulatory Documents, QA and Security documents, product requirements documents and all departmental policies and procedures.

Managed Ashion Compliance Manager in developing and implementing all HIPAA, Quality Assurance documents, technical documents and all departmental policies and procedures.

Pricing and Service Model: Established a competitive, detailed service line and pricing structure for Ashion’s portfolio of companies in line with the business strategy.

Selected all software and hardware, trained all staff, provided value proposition with product marketing and service marketing materials and built out the Centers Operation Manual for one healthcare system with five hospitals, (where each hospital had one center).

Spearheaded the definition of services stemming from pricing structure, which could be individually selected, catering to smaller Healthcare Systems, dramatically increasing customer base.

Technology Leadership: Oversaw evaluation, selection, and implementation of all company Information Systems, including a Healthcare Relationship Management System to track metrics and aggregate data and a Precision Medicine Platform for capturing clinical, genomic, and other molecular data.

Selected Office 365, MS Suite cloud based systems, and SharePoint for document control.

Evaluated four separate CRM systems and selected hc1.com; perked with vendor to develop unique solution, eliminating HIPAA concerns and aggregating data from hospitals in a corporate role up structure.

Reviewed the two market leading PMP systems, selecting Syapse for information system capabilities that empower Oncologists with real-time treatment options and research data empowering patient services.

Oversaw development of a cross platform mobile application for iOS and Android platforms. This mobile app will act as the virtual “laminated card” in a practicing physician’s pocket, providing an at-a-glance tool for genomic data interpretation. Utilized proprietary and open source digital content

Translational Genomics Research Institute (TGen) – Phoenix, AZ 2006 – 2014

Nonprofit institute developing diagnostics and treatments for major health problems utilizing advances from the Human Genome Project; $80M in revenue and ~300 employees.

DIRECTOR, OFFICE OF PROJECT MANAGEMENT

Recruited to create, build, and manage Project Management Office in close collaboration with President and COO on tactical planning and direction. Traversed company politics to successfully generate organizational buy-in and serve as key liaison between scientific and administrative operations. Oversaw international development effort of a biorepository. Recruited and supervised a high-performing 12-member team, conducted all staff performance management functions counseling them on their career path and managed a $500K budget with equal responsibility to the President. Held delegated Signing Authority from the COO, when required.

International Product Development: Directed entire international biorepository development, from coordination and construction, LIMS software development, through successful decisive, project implementation.

Overcame international building standards concerns for Luxembourg Biorepository labs not meeting requirements thorough conflict resolution, persuasive solutions, research and collaborating with the Board.

Pathology labs were introduced into health systems, creating a more efficient and timely process for garnering results as opposed to transporting samples to outside lab.

Collaborated proactively with the Head of the LNS and Nursing teams in planning and obtaining buy-in.

Financial Planning and Account Management: Developed a $34M+, three-year budget and a five-year operating financial model valued at $86M for biorepository implementation.

Product Commercialization: Drove quality assurance and validation standards development for the successful, commercialization for new innovative LIMS software, included web technology, embedded systems, database population and testing systems on time/on budget while meeting corporate goals.

Partnerships and Cost Savings: Partnered with Research Administration, Finance, Project Management, and TGen Foundation to develop and introduce an indirect cost-funding program.

Saved the institute $2M annually.

Identified new research strategies and business opportunities leading to numerous profitable contracts building to long term engagement with clinical partners and pharmaceutical partners.

PMO Build Out: Instituted and implemented policies and procedures while conducting strategic analyses and establishing PMO objectives utilizing a traditional and Lean approach to program delivery.

Overcame staffing obstacles during Oracle implementation, resolving without negative budget impact.

Produced and distributed complex project summaries, budgets and timelines as required for every grant, contract, and philanthropic donation for project allocation and expenditure justification.

Took on responsibility of institute annual budget and forecasting development for both Scientific and Administrative Staffs with positive results.

Technology Automation: Utilized SharePoint to execute, automate, and enhance strategic goals for scientific community supporting internal efforts to identify key research projects aligned with long-term goals.

Created greater awareness of institute’s goals while providing a forum to review current and future complex projects, allowing Scientific Community to move into a consistent, proactive budget year.

Allowed performance evaluation for Scientific Community in real time.

Philanthropic Leadership: Directed all fundraising development, installation, staffing, validation and certification of the fully operational Dorrance CLIA lab at TGen, resulting in a $2M gift.

Directed transition of Dorrance CLIA lab to the commercial entity Ashion Analytics, a CLIA-certified, CAP-accredited Genomics Sequencing Large Cancer Panel provider.

Prepared proposals aligned with philanthropic and legislative fundraising initiatives directed at high net worth individuals.

Installed top of the line, next generation sequencing and pathology equipment. Staffed lab ranging from Director to Technicians, trained all new personnel.

Validated the genomic tests that would be performed and certified as a CLIA Lab in AZ, with certifications from CA, FL, RI, MD, and PA.

Compliance and Security: Directed the implementation of Security and Privacy rules making TGen a HIPAA compliant Business Associate and Ashion Analytics a Covered Entity. Implemented all security procedures.

Medtronic – Tempe, AZ 2005 – 2006

A $28B+ world’s premier medical technology and services company.

SENIOR RELIABILITY AND QUALITY ASSURANCE ENGINEER

Hired to oversee quality control and improve underperforming Quality Department. Managed 60+ domestic and international suppliers, and managing a team of five. Performed risk assessments and collaborated with Semiconductor Operations Suppliers. Monitored and assessed Supplier quality to meet corporate goals. Developed and implemented improvement strategies.

ISO Success: Achieved 100% rating for on time Supplier Quality Systems ISO audits.

Performance Management: Directed team in corrective action improvement project, resulting in 28% decrease in open actions. Gained Supervisory experience and performed peer review requirements

Quality Improvement: Identified and cultivated enhancement opportunities for Wafer Fab processes by reduced risks for dropping Wafers and Wafer contamination.

GE Healthcare – Chandler, AZ 2000 – 2005

A 250-employee company that provides services in medical imaging and information technologies, medical diagnostics, and more.

PROCESS ENGINEER

Founding member in the research, development, and manufacturing for one of the world’s first DNA microarrays (CodeLinkTM). Led development and execution of manufacturing process improvements while mentoring and managing teams in project research and development. Ensured project deadlines and objectives were met successfully. Created and established employee training methods and safety protocols. Produced and distributed manufacturing guidelines supporting new product development. Followed 5S methodology in labs.

Cycle Time Improvement: Decreased post-manufacturing cycle time from 20+ days to seven days by applying automation and reducing processing time for the products. (Six Sigma Black Belt project)

Drove Operations: Designed and constructed BSL2 Laboratory, completing project two months ahead of schedule and $10K under budget while facilitating lab operations.

Cost and Time Savings: Reduced direct material costs by $5,200 per month and cycle time by 36 hours per month after generating and introducing reduction program.

Customer Service: Created and introduced process validating effects of raw materials in production, reducing customers complaints from 56% to 0% in one year.

Six Sigma: Received Green Belt and completed Black Belt project.

Education

MBA, Project Management, Keller Graduate School of Management, Mesa, AZ

BSE, Molecular and Cellular/Biochemistry Bioengineering, Arizona State University, Tempe, AZ

Graduate Certificate of Project Management, Keller Graduate School of Management, Mesa, AZ

Affiliations

AZ Technology Council – Phoenix AZ, Director, Board of Directors

The voice of Arizona’s nearly 800-member technology sector, which promotes research, education and access to a highly skilled workforce. Educated students through public presentations by engaging with, and positively impacting, diverse communities. January 2011 – November 2015

The American Cancer Society, ACS/ACS CAN – Phoenix AZ, District 7 ACT Lead

Cancer Action Network, Community Resources, Advocacy, Walk or Run Events, October 2015 – Present

Science / Healthcare / Biotechnology Tools / Computer Software

hc1.com • Syapse • Microsoft Word, Excel, PowerPoint, Project and Visio • PM Point • Bio4D

SharePoint • Skype • Oracle Financial Management

Skills / Key Words

Consumers • Accountability • Stewardship • Accountable • Flexible • Courteous • Decision-making • Punctual • HMO • Considerate • Written Communication Skills • Adapt To Changes • Professional Manner • Communicates Effectively • Professionalism • Inspiring • Integrity • Collaborative • Supervision • Cultivate Relationships • CMS • Motivate • Prioritization • Business Strategy • Communicate • Talent Acquisition • Medicare • Reporting • Public Presentations • Confident • HMO • Leadership Experience • Collaborate • Ability to Multi-Task • Executive Presence • Creditable • Hands-On

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